Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202303822908040 Date of Registration: 16/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Lung Flute ECO Evaluation - Phase 1
Official scientific title Evaluation of the Lung Flute ECO: to assist in sputum production
Brief summary describing the background and objectives of the trial Brief summary: Many people who are asked to produce a sputum specimen for diagnostic testing, such as testing for tuberculosis, are unable to produce a specimen of sufficient quantity and/or quality for a reliable test result. The Lung Flute ECO is a low-cost, non-invasive, biodegradable device that is designed to assist people to produce sputum. Evidence of the performance of the Lung Flute ECO to assist people to produce sputum in the intended setting of use is needed to inform future research and policy recommendations. Primary objective: • To determine the proportion of people who produce sputum (>1mL) after use of the Lung Flute ECO as compared to the proportion of people who produce sputum (>1mL) after video instruction on sputum production, in the intended setting of use Secondary objectives: • To evaluate the quality and quantity of sputum produced after use of the Lung Flute ECO as compared to after video instruction • To evaluate diagnostic test result obtained for people asked to produce sputum after use of Lung Flute ECO as compared to after video instruction • To evaluate the frequency, duration, and severity of adverse device reactions or symptom aggravation reported by people asked to produce sputum after use of the Lung Flute ECO as compared to after video instruction on sputum production • To evaluate the start of TB treatment initiation among all participants within 2 months post-enrolment
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 21/01/2022
Actual trial start date 07/03/2022
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 31/07/2022
Anticipated target sample size (number of participants) 1250
Actual target sample size (number of participants) 1271
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
G2021 114R1 Global Health Innovative Technology - GHIT
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Use of Lung Flute ECO Single-use of Lung Flute ECO for sputum production 20 sets of 2 blows with 10 seconds in between (typically 5-10 minutes) At the visit when the participant is allocated to use the Lung Flute ECO, the device is presented to the participant. The procedure is briefly explained and the participant is provided with a handheld phone or tablet with a 3-minute video demonstration of the usage of the Lung Flute ECO. Then the study personnel asks if the participant has questions and briefly answers any questions asked by the participant. The study personnel then accompanies the participant to the sputum production location and observes from a distance as the participant performs the first set of two blows. If needed, the study personnel provides additional feedback and/or demonstration of the use of the Lung Flute ECO to ensure the participant is using it as advised. The participant then follows along with a real-time video (~6 minutes in length) during the use of Lung Flute ECO. The video is provided in one of four commonly used languages depending on the preference of the participant. 1271
Control Group Video instructions for sputum production Single-time to watch the comparator video for sputum production Typically 3-5 minutes At the visit when the participant is allocated to the comparator method, a short video on how to produce sputum is shown to the participant. The video is ~4 minutes long. The video is provided in one of four commonly used languages depending on the preference of the participant. 1271 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Symptoms suggestive of pulmonary TB and/or an abnormal chest X-ray Able and willing to provide written informed consent (>20 years) or minor assent (15-20) and parental consent for participants 15-20 years. Able to understand instructions in one of the four commonly used languages (English, French, Fulfulde, Pidgin) • Asthma, with acute exacerbation in last two weeks (any attack within the last two weeks) • Dyspnea or respiratory distress, grade 3 or 4, in the last one week • Hypoxemia (SpO2 <90% in ambient air) • Hemoptysis (coughing up blood), in last one week • History of esophageal operation • Known eardrum damage or other middle ear lesions • Acute sinusitis, with documentation • Nosebleed, in the last one week • Nausea, grade 3 or 4, in the last two days • Vomiting grade 3 or 4, in the last two days • Other issue raised for exclusion based on the judgement of the clinical and/or study personnel Currently on TB treatment Inability to sit upright for 20 minutes 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 105 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/12/2021 Institute of Tropical Medicine Antwerp Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Nationalestraat 155,2000Antwerp Belguim Antwerp 2000 Belgium
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/02/2022 Cameroon Baptist Convention Health Board Institutional review Board
Ethics Committee Address
Street address City Postal code Country
Mbingo Bamenda N/A Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The estimated proportion of people who produce >1mL sputum after use of Lung Flute ECO as compared to after video instruction Visit1-Day 0,Visit 2- 2 hours to 14 days after visit 1
Secondary Outcome Sputum quantity (≤1mL, >1-2mL, 2-3mL, 3-4mL, >4mL) Sputum quality (Miller and Jones classification) Visit 1 Day 0,Visit 2-2hours to 14 days after visit 1
Secondary Outcome Estimated TB testing results (Xpert MTB/RIF Ultra) for people asked to produce sputum Visit1-Day 0,Visit 2-2 hours to 14 days after visit 1
Secondary Outcome Adverse events, with severity grading Summary data - end of study
Secondary Outcome Start of TB treatment Vital status a 2 months post-enrollment Tolerability of the Lung Flute ECO, visual analog scale Summary data - end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bamenda Regional Hospital Hospital Round about Bamenda Cameroon
Nkwen Baptist Hospital Finance Junction Bamenda Cameroon
Mboppi Baptist Hospital Mboppi ancien abattoir Douala Cameroon
Bonaberi Baptist Health Center Bonaberi echangeur Douala Cameroon
Meskine Baptist Hospital Meskine Louggol Maroua Cameroon
CMA Founangue Founangue Mbarmare Maroua Cameroon
HDNA Djamboutou Djamboutou Garoua Cameroon
Regional Hospital Garoua Kollere Garoua Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Global Health Innovative Technology Fund GHIT Ark Hills Sengokuyama Mori Tower 25F,1-9-10 Roppongi, Roppongi Tokyo 106-0032,JP Tokyo Japan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Institute of Tuberculosis RIT 3-1-24 Matsuyama, Kiyose, Tokyo 2048533 Tokyo Japan Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Ellen M.H Mitchell Nationalestraat 155,2000 Antwerp,Flanders Antwerp Belgium
Ippei Soma 5-8-100 Koyanagicho Fuchu-shi Tokyo 183-0013 Japan Tokyo Japan
Mbuli Cyrille Ndamnsah Hospital Roundabout Bamenda Cameroon
Melissa Sander Hospital Roundabout Bamenda Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Satoshi Mitarai mitarai@jata.or.jp 81424935711 3-1-24 Matsuyama, Kiyose
City Postal code Country Position/Affiliation
Tokyo 2048533 Japan Research Institute of Tuberculosis
Role Name Email Phone Street address
Scientific Enquiries Satoshi Mitarai mitarai@jata.or.jp 81424935711 3-1-24 Matsuyama,Kiyose
City Postal code Country Position/Affiliation
Tokyo 2048533 Japan Research Institute of Tuberculosis
Role Name Email Phone Street address
Public Enquiries Satoshi Mitarai mitarai@jata.or.jp 81424935711 3-1-24 Matsuyama,Kiyose
City Postal code Country Position/Affiliation
Tokyo 2048533 Japan Research Institute of Tuberculosis
Role Name Email Phone Street address
Scientific Enquiries Mbuli Cyrille Ndamnsah cyrillembuli@gmail.com +237670793083 Hospital Round about
City Postal code Country Position/Affiliation
Bamenda Cameroon Research Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to share IPD: Yes Description: Individual participant Data collected during the trial, after de-identification Informed Consent Form,Study Protocol Immediately following publication, with no end date Anyone who wishes to access data for any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information